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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Managing Side Effects of an MDR Case and Identified Contacts
Lisa True, RN MS, MDR Nurse Coordinator
Leslie Henry, RN, BSN, PHN, Nurse Consultant
Nurse Case Management of Drug‐Resistant TB: A Case Study
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Role of Nurses in Management of Drug‐Resistant TB
Nurses play vital role:
Guiding patients through long, difficult treatment
Minimizing side effects
Helping to prevent future cases
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Case Presentation
January 2014: 20 year old male with 3 months of cough, shortness ofbreath, and hemoptysis
Admitted to community hospital via emergency department
Cavitary chest x‐ray and CT scan
Sputum smear positive (3+)
Specimen sent to state lab for molecular testing for possible drug resistance
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Molecular Test Results
Pyrosequencing results from state labDrug Target Result Interpretation
INH KatG(313‐316) 315ACC mutation detected Associated with INH resistance
inhA(promoter)
No mutation detected
ahpC‐oxyR No mutations detected
Rifampin Rpob 531TTB mutation detected Associated with rifampin and rifabutin resistance
AMK, CAP, KM No mutation detected Suggests susceptibility to amikacin, kanamycin and capreomycin
Quinolones No mutation detected Suggests susceptibility to quinolones
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Initial Treatment
Initial MDR treatment regimen RIPE + IV Amikacin and moxifloxacin
INH and Rifampin discontinued after PSQ results
Additional drugs added pending results from CDC
Regimen: EMB, PZA, Amikacin, Moxifloxacin, Ethionamide, Linezolid, Cycloserine, and Vitamin B6
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MDR Treatment Principles (1)
Perform extensive patient evaluation prior to starting treatment
Use at least 4‐6 drugs to which isolate is susceptible (and preferablynot used previously)
1 bactericidal injectable
1 fluoroquinolone
Continue injectable for 6‐12 months post culture conversion
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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MDR Treatment Principles (2)
Continue at least 3 oral drugs for full treatment duration
Treat at least 18 months‐2 years after culture conversion
Never add a single drug to a failing regimen
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Additional Molecular Test Results
CDC Molecular Detection of Drug Resistance (Sanger Sequencing, embB and pncA only):
*A negative result (e.g. no mutation) does not rule out contributory mutations present elsewhere in the genome.
Locus (region) examined* Result Interpretation
Ethambutol Mutation GAC>GCC: Asp354Ala
Likely ethambutol resistant
pncA (promoter, coding region)
Silent mutation: GCC>GCT:Ala178Ala
Cannot rule out PZA resistance. The mutation detected is synonymous (silent) single nucleotide polymorphism and does not result in an amino acid change and is not considered clinically significant
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Social Situation and Discharge Planning
Patient has own bedroom in apartment with family
Family/Household: Two adult brothers are both TST positive with CXRs pending Father is TST positive Mother is TST negative
No children under five or immunocompromised individuals
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Discharge Home
Patient discharged home with following plan to minimize transmission: Avoid use of central heating Pt to keep window open in his room Pt to wear surgical mask when outside his room
Pt can meet with others outside
Mother to wear N‐95 when in pt’s room
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Criteria for Home Isolation*
Prior to meeting the criteria for non‐infectiousness, TB patients may be placed in home isolation if following criteria met: the patient has started on a standard multidrug anti‐TB treatment regimen;
no infants , children <5 years or persons with other severely immunocompromising conditions are present in the household or‐‐if present‐‐are on appropriate LTBI treatment or window period treatment for presumed LTBI;
all immunocompetent household members have been previously exposed to the patient; and
the patient is willing to follow the restrictions imposed by the local TB control program.
* CDPH/CTCA “Joint Guidelines for the Assessment of Tuberculosis Patient Infectiousness and Placement into High and Lower Risk Settings,” 2009
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Case Update
February 2014: Patient on MDR treatment for 5 weeks DSTs : R: INH, Rif, EMB
S: PZA, MFX, AK, CM, ETARegimen: PZA Amikacin IV via PICC lineMoxifloxacin Linezolid Ethionamide
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Provision of DOT
DOT standard of care for MDR patients
Benefits: close monitoring of side effects and ensure adherence
Resource Intensive: program used team approach Trained health educators to provide DOT Initially twice daily
Set up medisets: One at patient’s home, one at health department
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MDR Case: Managing Side Effects
Patient initially tolerated treatment well
Started experiencing nausea and vomiting about 10 minutes after medications
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Strategies for Managing Nausea (1)
Interventions which don’t require additional medications Eat a light snack before taking meds
Adjust timing of drug dosing without lowering overall dose
Mask medication odor
Have patient keep symptom diary to better identify time and pattern of symptoms
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Strategies for Managing Nausea (2)
Use an anti‐emetic (e.g. Compazine or Zofran) TIP: try a different anti‐emetic if first one doesn’t work
Provide drug holiday Other considerations: If anticipatory nausea or anxiety—try small dose anti‐anxiety drug Assess for other causes (e.g. pregnancy, hepatitis) SEA‐band or suppository
Case switched timing of ethionamide from split dose of 500 mg in am and 250mg in pm to taking 250 mg in am and 500 mg in pm
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Case Update: Mild Neuropathy
10 months of treatment, good bacteriologic and radiographicresponse to treatment, injectable discontinued in September
October 2014 (all medications taken at same time) PZA 2000 mg po daily
Moxifloxacin 400 mg po daily
Ethionamide 750 mg po daily
Linezolid 600 mg po daily
Reports intermittent numbness of lower extremities
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Management of Peripheral Neuropathy
Assess other potential causes of neuropathy
Increase Vitamin B6 to maximum daily dose of 200mg
Consider lowering the dose of likely offending drug if possible
Gabapentin may help alleviate symptoms
Neuropathy associated with linezolid is common after prolonged useand can be permanent
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Case Update: Management of Neuropathy
Increased Vitamin B6 to 150 mg daily
Linezolid dosage decreased to 300 mg po daily
No further episodes of neuropathy noted
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Case Update: Nausea and Elevation of LFTs
Later in October 2014 patient reported vomiting 30‐60 minutes aftermedications, LFTs mildly elevated
Zofran prescribed and taken 30 mins before medications with good results; PZA kept in the regimen
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Management of Elevated LFTs
PZA‐related hepatitis can be seen later in treatment, important tomonitor closely
If enzymes are >3 times upper limit and symptoms—stop all medications
Evaluate and treat other causes of hepatitis (check for Hep A, B, Cviruses, alcoholism)
Drug‐related hepatitis generally resolves after offending medication discontinued
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Common Side Effects of Second Line TB Medications
Drug Side Effects
Injectable agents Tinnitus, hearing loss, serum electrolyte abnormalities, renal toxicity
Quinolones Nausea, dizziness, insomnia, arthralgias, QT prolongation
Ethionamide Nausea, GI upset, anorexia, metallic taste, hypothyroidism
PAS Diarrhea, gas, hypothyroidism
Cycloserine Inability to concentrate/lethargy, depression, psychosis
Linezolid Myelosuppression, Peripheral neuropathy, diarrhea/nausea, optic neuropathy
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Toxicity Monitoring
Most 2nd & 3rd line TB drugs cause significant toxicity
Help your patient understand:
They will feel worse before they feel better
The toxicity symptoms will improve
There are ways to minimize toxicity symptoms
Develop an individualized monitoring plan
Use drug ramping for PAS, ETA, & CS
Vitamin B6 used with CS and LNZ
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Contact Investigation
Friends
School
Home/Family
WorkHospital
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Infectiousness of Patients with MDR TB
Drug‐resistant TB similar in transmissibility to drug‐susceptible TB
Most transmission occurs before treatment initiated
Smear‐positive cases transmit more efficiently than smear‐negativecases, but variability
Patients with MDR not more infectious, but duration ofinfectiousness may be prolonged if not started on effective regimen promptly
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Contact Investigation Sites (1)
Household (4) /Family (2)
• 1 clinical case (brother 1)
• 2 converters (mother, brother 2)
• 2 new positives (father and uncle)
• 1 TST ‐
Friends (28)
• 23 Girlfriend’s Family:
• 2 converters (girlfriend and nephew)
• 19 TST ‐
• 2 not evaluated
• 5 Friends : TST‐
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Contact Investigation Sites (2)
Worksite (16)
• 16 TST‐ first round testing; 14 TST ‐ second round testing
College (34)
• 34 students identified as contacts; 16 tested
• 13 TST‐
• 3 TST + (all foreign born, 1 prior positive, 1 neighbor)
Hospital (15)
• 15 IGRA negative
• 3 initial QFT converters
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Contact Investigation Continued: Interpreting results when using QFT (2)
Hospital investigation had 3 initial converters RN who did respiratory evaluation: exposed to patient on 1/4/14
Initial QFT on 1/17/14: positive (0.80)
Repeat QFT on 1/21/14 positive (1.6), CXR nl
RN declined treatment for LTBI due to concern about side effects
A third QFT done on 3/07/14 was negative (0.02), TST negative
Repeat QFT for 2 other “converters” were negative
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Contact Investigation Continued: Interpreting results when using QFT (3)
Use of IGRAs in contact investigations recommended and beneficialamong individuals with prior BCG history
Caution: false conversions at follow up testing may occur due to test variability
Consider reviewing quantitative results and interpret in context of exposure and evidence of transmission
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Strategies to Get Contacts Evaluated
Use incentives and Enablers
Health Officer Orders in California:Health and Safety Code Sections 120142 and 121364: both the state [public health] director and each local health officer may order examinations for TB infection for the purposes of directing preventive measures and for persons for whom the local health officer has reasonable grounds to determine are at heightened risk of tuberculosis exposure. However, these HSC sections don’t specify an enforcement procedure should the person fail to adhere to the order.
Perform testing in the field
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Treatment of Contacts to MDR
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LTBI Treatment for Family Contacts
Brother 1: clinical case, treated with MDR regimen
Brother 2: TST converter, treated with moxifloxacin
Father: new positive TST, treated with moxifloxacin
Mother: TST converter on second round testing, treated with moxifloxacin
Uncle: new positive TST, started treatment but stopped due to“intolerable” side effects
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Considerations in Treatment of Contacts to MDR TB
Thorough TB history of contacts critical to assess whether recent infection
Consider treatment thought to be due to infection with drug‐resistant TB
Use caution to lessen the risk of toxicity from treatment regimens
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Drug‐Resistant LTBI Treatment Options (1)
Treatment based on resistance pattern of the source case isolate
1992 CDC guidelines advise: treatment of MDR‐LTBI with 2 drugs to which isolate is susceptible (e.g. EMB and quinolone, PZA and quinolone or ethionamide and quinolone)
No randomized clinical trials to show clear efficacy of regimens
• Francis J. Curry National Tuberculosis Center and California Department of Public Health, 2008:Drug‐Resistant Tuberculosis: A Survival Guide for Clinicians, Second Edition, pg 206
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Drug‐Resistant LTBI Treatment Options (2)
Published case series show poor tolerability of multidrug regimensfor MDR LTBI, especially those including PZA
Small studies show use of moxifloxacin or levofloxacin alone might be effective in preventing progression
No treatment also an option given lack of efficacy data Monitor for 2 years with symptom review every 3‐6 months and chest x‐ray as clinically indicated
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Recent Report on Management of LTBI in Child Contacts
Exposure to teacher with MDR in California (R: INH, Rif, EMB)
118 children (ages 6‐13) with significant contact 31 children developed LTBI 26 treated with levofloxacin and PZA (per CDC guidelines)
12 required a change of therapy due to adverse effects (abdominal pain, arthralgias/myalgia and elevated transaminases)
15 children completed LTBI treatment—no progression to active disease during 24 months of follow‐up
Adler‐Shohet FC, Low J, Carson M, Girma H, Singh J. Management of latent tuberculosis infection in child contacts of multidrug‐resistant tuberculosis. Pediatr Infect Dis J. 2014
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Contact Investigation Continued: Addressing Side effects to LTBI Treatment
Close Friends: Girlfriend’s nephew: 11 years old TST positive
Started on levofloxacin
Began experiencing knee pain and “walking funny”
Mom became distraught
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Contact Investigation Continued: Addressing Side effects to LTBI Treatment(2)
Nephew evaluated by pediatricianLevofloxacin discontinued Plan to follow every 6 months
Lower threshold for tolerating side effects with LTBI treatment sincebenefits are not well established
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Use of Fluoroquinolones in Children
Fluoroquinolones commonly used in children for other infections and is well tolerated
Black box warning highlights concern for musculoskeletal adverse effects
Lack of data on effect of long‐term use of fluoroquinolones
Despite limited data in children, fluoroquinolones are recommendedas part of multidrug regimen for treatment of MDR TB and MDR LTBI
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Managing Side Effects to LTBI Treatment
Benefits: Potential Decrease Disease Risk
Risk: Possible Significant Side Effects
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Summary: Positive Outcomes and Nurse Case Management
Patient doing well on treatment, no permanent side effects Careful monitoring of response to treatment, side effects and signs of toxicity
Team approach for DOT
Brother (clinical case) completed 15 month regimen without complications Early identification of contacts (good rapport with case) Effective communication with patient and family
3 family members and 2 friends completed MDR LTBI Thorough contact investigation Case management of contacts to help them get through LTBI
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Nurse Case Management of Drug-Resistant Tuberculosis WebinarMay 20, 2015 Curry International Tuberculosis Center
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Acknowledgements
Nurse Case Managers in Local Health Departments
Gayle Schack
Pennan Barry
Neha Shah
Gisela Schecter
Randall Reves